A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France

Psoriasis Clinical Trial

— REALIZE  

Official title:

Real Life Data for Otezla Evidence: Assessing Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757013
• Other study ID #: CC-10004-PSOR-021
• Secondary ID: U1111-1218-9791
• Status: Completed
• Start date: September 25, 2018
• Est. completion date: September 10, 2021

Study information

• Verified date: December 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.

REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).

Description:

Eligible patients will be identified and invited to enroll from approximately 100 dermatologists in France practicing in public hospitals (or private clinics) or private practice. Patients will be followed over 12 months after initiation of apremilast or until discontinuation of apremilast whatever the earlier. Given the observational nature of the study, apremilast dosing and duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice. Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating dermatologist every 6 months. In this study, patients will be followed up at most 12 months after apremilast initiation.

During this study, it is expected to collect data at inclusion (enrolment visit) and around 6 months and 12 months after apremilast initiation, on electronic case report forms (eCRF) by the dermatologist after performing a visit around 6 and 12 months to evaluate the treatment response following the apremilast initiation.

Due to the observational nature of the study, the study protocol does not require any specific tests or additional examinations. All assessments will be recorded in the electronic case report form (eCRF) according to the normal practice of the treating dermatologist. Self-questionnaires will be filled by the patient when visiting his/her dermatologist.

Total duration of the study is 2 years and 6 months, which includes an enrollment period of 1 year and 6 months and a follow up period of up to 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: September 10, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged at least 18 years

• Patient with a diagnosis of stable moderate to severe chronic plaque psoriasis

• For whom the treating dermatologist has made the decision to initiate apremilast treatment in accordance with the local label and reimbursement criteria i.e. a history of failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy)

• Patient having started apremilast up to 4 weeks before the enrolment visit for treatment of moderate to severe chronic plaque psoriasis even if apremilast has been stopped before inclusion in the study

• Patient literate and willing to fill in questionnaires

• Non-opposition form signed by the investigator indicating that the patient received information about the study, and orally agreed.

Exclusion Criteria:

• Patient who refuses to participate in the study or is unable to give his/her oral consent

• Patient having participated in an interventional study in the last 30 days

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Apremilast
Apremilast

Locations

Country	Name	City	State
France	Private Practice, Amiens	Amiens
France	Saint-Joseph Clinic, Angouleme	Angouleme
France	Private Practice, Antibes	Antibes
France	Private Practice 2, Antony	Antony
France	Private Practice 2, Arcachon	Arcachon
France	Private Practice, Argenteuil	Argenteuil
France	Private Practice, Aubière	Aubière
France	Private Practice, Auch	Auch
France	Auxerre Hospital	Auxerre
France	Henri Duffaut Hospital	Avignon Cedex 9
France	Private Practice, Bègles	Bègles
France	Private Practice, Besançon	Besançon
France	Reims-Bezannes Polyclinic	Bezannes
France	Reims-Bezannes Polyclinic 2	Bezannes
France	Reims-Bezannes Polyclinic 3	Bezannes
France	Private Practice, Biarritz	Biarritz
France	Private Practice, Bordeaux	Bordeaux
France	Docteur Duchenne Hospital	Boulogne-sur-Mer
France	Docteur Duchenne Hospital 2	Boulogne-sur-Mer
France	Private Practice 2, Caen	Caen
France	Private Practice 3, Caen	Caen
France	Private Practice, Caen	Caen
France	Private Practice, Cannes	Cannes
France	Private Practice 2, Chalons-en-Champagne	Chalons-en -Champagne
France	Chalons-en-Champagne Hospital	Chalons-en-Champagne
France	Private Practice, Chalons-en-Champagne	Chalons-en-Champagne
France	Private Practice, Chamalières	Chamalières
France	Métropole Savoie Hospital	Chambéry
France	Trousseau Hospital	Chambray-Les-Tours Cedex
France	Private Practice 2, Chartres	Chartres
France	Private Practice, Chartres	Chartres
France	New Sud Francilien Hospital	Corbeil Essonnes
France	GH de Dax, Dax	Dax
France	Private Practice 2, Dijon	Dijon
France	Private Practice 3, Dijon	Dijon
France	Private Practice, Dijon	Dijon
France	Private Practice, Dole	Dole
France	Victor Jousselin Hospital	Dreux
France	Emile Durkheim Hospital - Saint Jean Health Center	Epinal Cedex
France	Private Practice, Essey-les-Nancy	Essey-les-Nancy
France	Golfe de St-Tropez Clinic	Gassin
France	Private Practice 2, Joue les Tours	Joue les Tours
France	Private Practice 3, Joue les Tours	Joue les Tours
France	Private Practice, Joue les Tours	Joue les Tours
France	Private Practice, L'Union	L'Union
France	Private Practice 2, La Teste-de-Buch	La Teste-de-Buch
France	Private Practice, La Teste-de-Buch	La Teste-de-Buch
France	Private Practice, La Valette du Var	La Valette du Var
France	Private Practice, La Varenne Saint Hilaire	La Varenne Saint Hilaire
France	Private Practice 2, Laval	Laval
France	Private Practice, Laval	Laval
France	Mans Hospital	Le Mans
France	Mans Hospital 2	Le Mans
France	Private Practice, Le Mans	Le Mans
France	Private Practice, Le-Bourget-du-Lac	Le-Bourget-du-Lac
France	Private Practice, Lille	Lille
France	Private Practice 2, Luce	Luce
France	Private Practice, Luce	Luce
France	Edouard Herriot Hospital	Lyon
France	Private Practice 2, Lyon	Lyon
France	Private Practice 4, Lyon	Lyon
France	Private Practice, Lyon	Lyon
France	Private Practice, Martigues	Martigues
France	Annecy Genevois Hospital, Metz Tessy	Metz Tessy
France	Private Practice, Meudon-la-Forêt	Meudon-la-Forêt
France	Private Practice, Muret	Muret
France	Hotel Dieu Hospital, Dermatologic Clinic	Nantes
France	Private Practice, Narbonne	Narbonne
France	Private Practice, Nevers	Nevers
France	Private Practice 2, Nice	Nice
France	Private Practice 3, Nice	Nice
France	Private Practice, Nogent-Le-Rotrou	Nogent-Le-Rotrou
France	Private Practice, Orléans	Orléans
France	Private Practice 2, Paris	Paris
France	Private Practice 3, Paris	Paris
France	Private Practice 4, Paris	Paris
France	Private Practice 5, Paris	Paris
France	Private Practice, Paris	Paris
France	Private Practice, Pontarlier	Pontarlier
France	Private Practice, Pontoise	Pontoise
France	CHI de Cornouaille - Laennec	Quimper
France	Private Practice, Quimper	Quimper
France	Mathilde II Clinic	Rouen
France	Private Practice, Saint-Etienne	Saint-Etienne
France	Saint-Etienne Hospital	St Priest en Jarez
France	Private Practice, Torcy	Torcy
France	BCRM Toulon - HIA Saint-Anne	Toulon Cedex 9
France	Private Practice, Toulouse	Toulouse
France	Nord Franche-Comté Hospital	Trevenans
France	Valence Hospital	Valence
France	Valence Hospital 2	Valence
France	Valence Hospital 3	Valence
France	Jacques Lacarin Hospital	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Patient Benefit Index score (PBI-S) =1 at 6 months after initiation of apremilast.	The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.	Up to 6 months
Secondary	Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation	The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.	Up to 6 months
Secondary	Proportion of patients with PBI-S=4 at 6 months after apremilast initiation	The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits	Up to 6 months
Secondary	Adherence Rate	The adherence rate will be defined as the percentage of patients pursuing the treatment with apremilast at 12 months after the initiation of apremilast.. The calculation will take into account the patients having started and discontinued apremilast within 4 weeks before the enrolment visit.	Up to 12 months
Secondary	Percentage of patients substituting apremilast	The percentage of patients substituting apremilast by a biologic will be estimated by the Kaplan Meier method. The date of origin will be defined as the date apremilast has been started.	Up to 24 months
Secondary	Dermatology Life Quality Index (DLQI)	DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.	Up to 24 months
Secondary	Proportion of patients with DLQI = 5	DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.	Up to 24 months
Secondary	Proportion of patients achieving DLQI 0/1	DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.	Up to 24 months
Secondary	Change in DLQI score from M0 to M6 and M12	DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.	Up to 12 months
Secondary	Proportion of patients with improvement in DLQI = 5 points between M0 and M6, M12	DLQ is a 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period is 7 days. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.	Up to 12 months
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM9)	TSQM-9 is a 9-item validated self-administered questionnaire used to evaluate the patient's overall satisfaction with study treatment. The TSQM-9 consists of 8 items that make up 3 specific scales (effectiveness, side effects, convenience) and one global satisfaction scale. Scale scores are transformed into scores from 0 to 100 with higher scores representing higher satisfaction in that domain.	Up to 24 months
Secondary	Proportion of patients with sPGA 0 or 1	sPGA static physician global assessment is defined as single-item-5-point categorized scale reflecting the physician's assessment of psoriasis severity. This scale ranges from 0 to 4.	Up to 24 months
Secondary	Change in sPGA from baseline to M6 and M12	sPGA static physician global assessment is defined as single-item-5-point categorized scale reflecting the physician's assessment of psoriasis severity. This scale ranges from 0 to 4.	Up to 12 months
Secondary	Percentage of BSA (%BSA) involved at M0, M6, M12	BSA is the measurement of the body area involved in relation to the whole body surface	Up to 12 months
Secondary	Change in % BSA from M0 to M6, M12	BSA is the measurement of the body area involved in relation to the whole body surface	Up to 12 months
Secondary	Psoriasis Area Severity Index (PASI) at M0, M6, M12	PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis	Up to 12 months
Secondary	Change in PASI from M0 to M6, M12	PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis	Up to 12 months
Secondary	Proportion of patients achieving PASI50 at M6, M12	PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis	Up to 12 months
Secondary	Proportion of patients achieving PASI75 at M6, M12.	PASI is a common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis	Up to 12 months
Secondary	Adverse Events (AEs)	Number of participants with adverse events	Up to 24 months
Secondary	Duration of disease	Duration of disease will be defined as the length of time the disease has been present, indication by months of years.	Baseline
Secondary	Number of areas of plaque psoriasis	The number of area of plaque psoriasis will be defined by the number of area observed by the Investigator	Baseline
Secondary	Type of chronic psoriasis involved	Types if chronic psoriasis, scalp, palmoplantar, genital	Baseline
Secondary	The number of lines of previous systemic treatments	Number of lines of previous systemic treatments will be described by one line, two lines	Baseline
Secondary	Type of systemic therapy previously administered	The type of systemic therapies includes corticosteroids, topical, other classification of medications	Baseline
Secondary	Duration of previous chronic psoriasis treatment	The duration of previous treatment will be described in months, years.	Baseline
Secondary	Number of motivations of the prescription of apremilast	Motivations will be described by the number of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.	Up to 24 months
Secondary	Percentage of motivations of the prescription of apremilast	Motivations will be described by the percentage of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.	Up to 24 months

External Links

•   AmgenTrials clinical trials website